PILOCARPINE HYDRCHLORIDE tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

PILOCARPINE HYDROCHLORIDE (UNII: 0WW6D218XJ) (PILOCARPINE - UNII:01MI4Q9DI3)

Saatavilla:

Bryant Ranch Prepack

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Pilocarpine hydrochloride tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome. Pilocarpine hydrochloride tablets are contraindicated in patients with uncontrolled asthma, known hypersensitivity to pilocarpine, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle closure) glaucoma.

Tuoteyhteenveto:

Pilocarpine hydrochloride tablets 5 mg are supplied as white, round, film coated tablets, debossed with "P" over "1R0" on one side and other side is plain. They are supplied as follows: Bottles of 100 (NDC 63629-8439) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant containers as defined in the USP. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

PILOCARPINE HYDRCHLORIDE- PILOCARPINE HYDRCHLORIDE TABLET, FILM COATED
BRYANT RANCH PREPACK
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PILOCARPINE HYDROCHLORIDE TABLETS
5 MG
RX ONLY
DESCRIPTION:
Pilocarpine hydrochloride tablets contain pilocarpine hydrochloride, a
cholinergic agonist
for oral use. Pilocarpine hydrochloride is a hygroscopic, odorless,
bitter tasting white
crystal or powder, which is soluble in water and alcohol and virtually
insoluble in most
non-polar solvents. Pilocarpine hydrochloride, with a chemical name of
(3_S-cis_)-2 (3_H_)-
Furanone, 3-ethyldihydro-4-[(1-methyl-1_H_-imidazol-5-yl) methyl]
monohydrochloride,
has a molecular weight of 244.72.
Each pilocarpine hydrochloride tablet for oral administration contains
5 mg of pilocarpine
hydrochloride. In addition, it also contains the following inactive
ingredients:
hypromellose, microcrystalline cellulose, polyethylene glycol,
polysorbate 80, stearic acid
and titanium dioxide.
CLINICAL PHARMACOLOGY:
PHARMACODYNAMICS: Pilocarpine is a cholinergic parasympathomimetic
agent exerting
a broad spectrum of pharmacologic effects with predominant muscarinic
action.
Pilocarpine, in appropriate dosage, can increase secretion by the
exocrine glands. The
sweat, salivary, lacrimal, gastric, pancreatic, and intestinal glands
and the mucous cells
of the respiratory tract may be stimulated. When applied topically to
the eye as a single
dose it causes miosis, spasm of accommodation, and may cause a
transitory rise in
intraocular pressure followed by a more persistent fall. Dose-related
smooth muscle
stimulation of the intestinal tract may cause increased tone,
increased motility, spasm,
and tenesmus. Bronchial smooth muscle tone may increase. The tone and
motility of
urinary tract, gallbladder, and biliary duct smooth muscle may be
enhanced. Pilocarpine
may have paradoxical effects on the cardiovascular system. The
expected effect of a
muscarinic agonist is vasodepression, but administration of
pilocarpine may produce
hypertension after a brief episode of hypotension. Bradycardia and
tachycar